About this role
We are seeking two Clinical Writers to join a global project starting after the summer. The roles will be responsible for the development, review and delivery of high-quality clinical and non-clinical regulatory documents across multiple therapeutic areas, ensuring compliance with regulatory requirements, client standards and industry best practices. Key Responsibilities Author, edit, and review a broad range of clinical and non-clinical regulatory documents, including: Clinical Study Protocols and Amendments Clinical Study Reports (CSRs) Investigator's Brochures (IBs) Clinical Summaries and Overviews Common Technical Document (CTD) Modules Non-clinical Study Reports and Summaries Integrated Summaries of Safety (ISS) and Efficacy (ISE) Regulatory briefing documents and responses to Health Authorities Interpret and present complex scientific, clinical, statistical, and non-clinical data in a clear, concise, and scientifically accurate manner. Coordinate document development activities with multidisciplinary teams and external stakeholders. Ensure documents meet applicable regulatory requirements, including ICH, EMA, FDA, MHRA, and other global guidelines. Manage document timelines and contribute to project planning activities. Required Qualifications and Experience Proven experience in regulatory or clinical medical writing within the pharmaceutical, biotechnology, CRO, or medical communications industry (minimum 5 years' experience) Demonstrated experience authoring both clinical and non-clinical regulatory documentation. Strong understanding of drug development processes and regulatory submission requirements. Familiarity with ICH guidelines, GCP, GLP, and global regulatory frameworks. Details 12-month contract ~20 hours per week (sometimes more depending on project phase) Remote in Europe or US Mid-September start